| CTRI Number |
CTRI/2024/06/069195 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
28/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of management in adult patients having obstruction in their main windpipe |
|
Scientific Title of Study
|
Prospective Observational Study Of Perioperative Airway Management In Adult Patients With Central Airway Obstruction |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Madhavi Shetmahajan |
| Designation |
Professor |
| Affiliation |
Tata memorial Centre, Mumbai |
| Address |
Dept of Anaesthesiology, Critical Care and Pain, tata Memorial hospital, parel, mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
9819372075 |
| Fax |
|
| Email |
mshetmahajan@hotmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Madhavi Shetmahajan |
| Designation |
Professor |
| Affiliation |
Tata memorial Centre, Mumbai |
| Address |
Dept of Anaesthesiology, Critical Care and Pain, tata Memorial hospital, parel, mumbai
MAHARASHTRA 400012 India |
| Phone |
9819372075 |
| Fax |
|
| Email |
mshetmahajan@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
J Ashwin priyadarshan |
| Designation |
Junior Registrar II |
| Affiliation |
Tata Memorial Centre, Mumbai |
| Address |
Dept of Anaesthesiology, Critical Care and Pain, tata Memorial hospital, parel, mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
8456063581 |
| Fax |
|
| Email |
aswinpriyadarshan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Centre, E borges marg, parel, mumbai 400012 india |
|
|
Primary Sponsor
|
| Name |
Tata memorial Centre Mumbai |
| Address |
Tata memorial centre, E borges rd, Parel, Mumbai , India 400012 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Madhavi Shetmahajan |
Tata memorial Hospital |
Operation theatre complex, anaesthesia department, E Borges Marg, Parel, mumbai 400012 India Mumbai MAHARASHTRA |
9819372075
mshetmahajan@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Centre Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients with central airway obstruction undergoing anaesthesia in emergency and elective setting |
|
| ExclusionCriteria |
| Details |
Paediatric patients
Supraglottic obstruction and obstruction distal to mainstem bronchi
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Preference of different types of airway management plan based on site and degree of obstruction |
After intubation or alternative airway control intraoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
2. Success rate of primary plan (plan A) of airway management.
3. Complications during airway management.
4. Number of cases with uncontrolled desaturation to less than 90 percent during airway management.
|
Intraoperatively, postoperative day 1, at discharge from hospital |
|
|
Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Airway obstruction is a potentially life threatening condition with a wide variety of aetiologies that can lead to a number of complications ranging from respiratory failure, arrhythmias, cardiac arrest and even death. In general, airway obstruction is broadly classified into upper airway obstruction which refers to the obstruction of air flow in the portion of the airway that extends from the nose till the trachea and therefore includes the nasopharynx and larynx. Central airway obstruction which refers to the obstruction of airflow in the trachea and mainstem bronchi. Lower airway obstruction refers to the obstruction distal to the mainstem bronchi. Causes of central airway obstruction are typically classified as malignant or nonmalignant or in accordance to the location ie intraluminal or extraluminal or according to the nature of the obstruction ie dynamic (eg;tracheobronchomalacia) or fixed. Management of central airway obstruction is complex and challenging. Management is usually individualised rather than protocolised. There are no clear guidelines regarding anaesthesia techniques for airway management. General anaesthesia with inhalational or intravenous techniques, with or without muscle relaxants or awake techniques for airway control may be used based on the type and degree of airway obstruction, experience of the anaesthesiologist and availability of equipment. This prospective observational study is aimed at understanding the airway management practices and outcomes in patients with central airway obstruction undergoing anaesthesia in our institute.
The main objectives of the study is to 1)Assessment of the location, extent and nature of the obstruction based on radioimaging/fibreoptic nasoendoscopy, PFT and other modalities. 2)Assessment of the airway equipment used to secure the airway based on the location, extent, nature of the obstruction and other patient factors. 3)Assessment of the factors considered while planning the airway strategy (eg;awake or under GA). 4)Assess the impact of the proposed airway management in patient outcome. The total study duration is 2 years.The total sample size is 200 patients. All adult patients in Tata Memorial Hospital,Parel with central airway obstruction undergoing anaesthesia in emergency and elective setting will be included in the study after taking an written informed consent. Data will be collected in the Case Record Form. Details regarding patient characteristics, surgical procedure and anaesthesia details will be collected prospectively from the patients’ electronic and physical records. Details regarding airway management plan and its success, failure and complications will be captured. Demographic data
will be summarized with descriptive statistics. Continuous data will be
represented as mean (Standard deviation), or Median (IQR) and categorical data
will be reported in counts (percentage) respectively. The Shapiro-Wilk’s test
will be used to check normality of each variable. Categorical data
will be compared using chi square test such like Pearson’s chi square test and
fisher’s exact test. Comparison of continuous data will be done by using t test
or Mann Whitney U test. |